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NCT06390345 · ClinicalTrials.gov registry record · NA

Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

A NA study of Obstructive Sleep Apnea and Overweight and Obesity, sponsored by Seattle Institute for Biomedical and Clinical Research.

Recruiting
Registry status
NA
Development phase
400
Enrollment target
5
Study locations

NCT06390345: Recruiting NA study of Obstructive Sleep Apnea and Overweight and Obesity, sponsored by Seattle Institute for Biomedical and Clinical Research.

NCT06390345 is a NA study of Obstructive Sleep Apnea and Overweight and Obesity that is actively recruiting participants, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 400 participants, above the 219-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (83% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06390345, a NA study of Obstructive Sleep Apnea and Overweight and Obesity, is actively recruiting participants, sponsored by Seattle Institute for Biomedical and Clinical Research.

RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
5
Study locations

Study Summary

The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

Primary Outcome

The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.

Conditions Studied

Obstructive Sleep Apnea Overweight and Obesity Chronic Obstructive Pulmonary Disease

Interventions

  • OTHER Enhanced Usual Care
  • OTHER FOCuSEd Integrated Intervention

Study Locations (5)

Washington

  • VA Puget Sound Health Care System - Seattle
  • Mann-Grandstaff VA Medical Center - Spokane

Idaho

  • Boise VA Medical Center - Boise

Illinois

  • Jesse Brown VA Medical Center - Chicago

Minnesota

  • Minneapolis VA Health Care System - Minneapolis

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2024-07-29
Est. Completion 2028-10-01
Phase NA
Seattle Institute for Biomedical and Clinical Research

43 total trials

What NCT06390345 shows while recruiting

NCT06390345 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 219-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (83% higher).

The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care is the first listed.

NCT06390345 lists 5 locations in 4 states (Washington, Idaho, Illinois).

Frequently Asked Questions

What is clinical trial NCT06390345 about?

NCT06390345 is a clinical study titled "Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention". The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible partici...

What is the current status of trial NCT06390345?

This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-07-29. Estimated completion is 2028-10-01.

What conditions does trial NCT06390345 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea, Overweight and Obesity, Chronic Obstructive Pulmonary Disease.

What interventions are being tested in trial NCT06390345?

The interventions under investigation include: Enhanced Usual Care (OTHER), FOCuSEd Integrated Intervention (OTHER).

Who is sponsoring clinical trial NCT06390345?

This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06390345 being conducted?

This trial has 5 study locations across Idaho, Illinois, Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Obstructive Sleep Apnea

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06390345's enrollment target sits among peer trials

400 18th of 155 higher than 138 of 155 other Obstructive Sleep Apnea trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06390345

Source: ClinicalTrials.gov NCT06390345, the US trial registry maintained by the National Library of Medicine. NCT06390345 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.